Astute Medical - 2014 Fierce 15

CEO: Christopher Hibberd
Based: San Diego, CA
Founded: 2007

The scoop: The NephroCheck Test System tests urine samples for two biomarkers of acute kidney injury (also called acute renal failure). The 20-minute test assesses the likelihood of a patient developing AKI within the next 12 hours using a 0-10 risk scale.

"Kidney function is important to maintain and clear your system of many toxins. If your kidneys don't function, pretty much everything that happens to you in the hospital is about twice as bad," said chief scientific officer and co-founder Paul McPherson in an interview.

What makes Astute Medical Fierce: In September, the FDA cleared the NephroCheck Test System, making it the first and only diagnostic for AKI. The product was cleared through the de novo pathway for novel devices lacking a "substantially equivalent" predecessor that are of low to moderate risk. The use of that pathway by the FDA affirms that the diagnostic is the first regulated product to assess the likelihood of developing AKI.

McPherson said that in clinical trials the test predicted AKI with an accuracy of 92% based on the risk scale, adding that "Part of our FDA validation was to validate a cutoff for AKI prediction at a certain (numerical) value on the scale."

Astute is also in a promising market, for AKI is a serious condition; a recent study found that hospitalized patients with AKI had a 30% mortality rate at one year, twice that of a heart attack. According to Astute, AKI is associated with more than twice the length of hospital stay, higher readmission rates (9.3% vs. 28.6% for severe cases of the condition) and a greater cost to the healthcare system ($13,800 vs. $49,000 per patient).

Because the condition has few symptoms, it can't be diagnosed without a diagnostic, McPherson said. "The NephroCheck provides this early alarm so they can initiate this supportive and preventative bundle earlier when it will really matter to the patient," he explained, adding that there are no therapeutics to treat AKI, making early detection even more important.

Astute has the first-mover advantage thanks to cutting-edge science. "We had over 300 biomarkers as candidates (for predicting AKI) at the start," CEO and co-founder Christopher Hibberd told FierceMedicalDevices. "We did more biomarkers validation and testing than probably had been done by the sum of our competitors combined."

The company also boasts a tie-up with Ortho-Clinical Diagnostics, now a member of the Carlyle Group. OCD's $20 million series D investment in July was in addition to a $40 million Series C venture capital round that was one of the largest among life science companies in 2012.

What to look for: The 50-person company is hiring 25 sales reps as it seeks to successfully commercialize the product. Ortho-Clinical is also Astute's exclusive sales agent. And in about two years, the NephroCheck will be available on Ortho-Clinical's Vitros line of automated testing systems, Hibberd said, because "over time as the volumes increase, customers will want a more automated solution."

Unlike other device and diagnostic companies, Astute won't have to haggle with insurance companies and the Centers for Medicare and Medicaid Services. That's because the NephroCheck will be reimbursed under the diagnosis-related group system for inpatients, since the test will be administered inside the hospital.

So far, the product has been used commercially on a small scale in Germany and France, but the company has global ambitions. "I'm flying off to China next week," Hibberd said. Still, the U.S. market is the most immediate focus.

The CEO said he is aiming for profitability by 2016. "Profitability can come sooner if you don't invest in the pipeline, but we are committed to bringing forth new products, so we continue to make that investment," he said. Astute's research areas include abdominal pain, acute coronary syndromes, cerebrovascular injury, kidney injury and sepsis. -- Varun Saxena (email | Twitter)

For more:
First Dx for kidney failure approved by FDA
Astute Medical reels in $40.4M Series C for biomarker lab test Dx

Astute Medical - 2014 Fierce 15